An observational study in Pleural Effusions, sponsored by University of Arizona. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by University of Arizona · Observational
The goal of this study is to evaluate the EPISEEK-MPE laboratory test for diagnosis of malignant (cancerous) pleural effusions verses pleural effusions caused by a non-cancer condition. The study uses excess samples drained from around the lung as part of a patient's regular care. The main questions the study aims to answer are:
Participants will be asked to donate a small portion of the excess fluid drained from around the lung for research. Participants will also give permission to collect data from the medical records.
In clinical practice, it remains a challenge to distinguish between malignant pleural effusion (MPE) and benign pleural effusion (BPE). Because of the limitations of conventional cytology methods, there is an urgent need to develop a more accurate and effective method for the efficient diagnosis of MPE. In collaboration with the University of Arizona, Precision Epigenomics has developed the EPISEEK-MPE test that has the potential to be an effective complimentary tool for cytology in the process of differential diagnosis. The aim of this project is to conduct a multi-site clinical validation study to establish the EPISEEK-MPE test as a new commercial molecular test for the diagnosis of malignant pleural effusions. The study will: 1) Establish the diagnostic value of the EPISEEK_MPE liquid biopsy assay to identify cancer in pleural effusion and 2) Validate the EPISEEK-MPE liquid biopsy assay for cancer detection in pleural effusion. The long-term goal of this project is to bring the field of pathology a new diagnostic tool for the diagnosis of malignant pleural effusions.
169 studies on the registry are indexed under Pleural Effusion, Malignant; 39 are open to participants now.
This study's planned enrollment of 625 is above the median of 112 across 37 observational studies indexed under Pleural Effusion, Malignant.
Browse Pleural Effusion, Malignant studies →University of Arizona is the lead sponsor of 476 studies on the registry; 88 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 30 (59%) have results posted.
Compared within Pleural Effusion, Malignant, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Pleural Effusion. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Adult patients that are having pleural fluid drained as part of clinical care.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
- Insufficient fluid available following clinical drainage procedure
Patients with pleural effusions due to infection, heart failure, atelectasis, bronchial obstruction, pulmonary embolism, etc. To be included in the benign group, subjects cannot have any cancer-related history within the last 15 years and chest radiograph will be without evidence of lung mass / malignancy.
Patients with a known cancer diagnosis, but with cytology negative pleural fluid.
Patients with known cancer and a cytology positive pleural fluid sample.
Diagnostic performance
To determine the diagnostic performance characteristics of the EPISEEK-MPE test in terms of accuracy, specificity, sensitivity, negative predictive value (NPV), and positive predictive value (PPV).
Time frame: From enrollment to the completion of the study analysis an average of 2 years
Predictive value
Investigators will evaluate the association of the methylation signal from the EPISEEK-MPE test with overall survival.
Time frame: From enrollment to 1 year post procedure
Validate EPISEEK-MPE
Establish the performance specifications of EPISEEK-MPE as a laboratory developed test including: 1. Reportable range 2. Analytical sensitivity 3. Precision 4. Analytical specificity 5. Accuracy 6. Reference interval
Time frame: From enrollment to the completion of the study analysis
Methylation signal
Determine the methylation signal relationship with clinical variables such as age, race, gender, and ethnicity.
Time frame: At baseline
Plan to share: No — This is an exploratory study with a commercial entity and data is considered joint intellectual property.
No publications or documents are linked to this record.
Started Jan 2025 (actual). Primary completion is estimated for Dec 2026, 23 months after the start.
Of 22 observational studies under Pleural Effusion, Malignant, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 44. This study's planned 23 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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